ofloxacin

Generic: ofloxacin

Labeler: redpharm drug
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ofloxacin
Generic Name ofloxacin
Labeler redpharm drug
Dosage Form SOLUTION
Routes
AURICULAR (OTIC)
Active Ingredients

ofloxacin 3 mg/mL

Manufacturer
Redpharm Drug

Identifiers & Regulatory

Product NDC 67296-2159
Product ID 67296-2159_45d262c9-d942-0c46-e063-6394a90aae60
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217903
Listing Expiration 2026-12-31
Marketing Start 2024-03-01

Pharmacologic Class

Established (EPC)
quinolone antimicrobial [epc]
Chemical Structure
quinolones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 672962159
Hyphenated Format 67296-2159

Supplemental Identifiers

RxCUI
242446
UPC
0369315320105 0369315320051
UNII
A4P49JAZ9H
NUI
N0000175937 M0023650

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name ofloxacin (source: ndc)
Generic Name ofloxacin (source: ndc)
Application Number ANDA217903 (source: ndc)
Routes
AURICULAR (OTIC)
source: ndc

Resolved Composition

Strengths
  • 3 mg/mL
source: ndc
Packaging
  • 5 mL in 1 BOTTLE, DROPPER (67296-2159-5)
source: ndc

Packages (1)

67296-2159-5 5 mL in 1 BOTTLE, DROPPER (67296-2159-5)

Ingredients (1)

ofloxacin (3 mg/mL)

Linked Drug Pages (1)

OFLOXACIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["AURICULAR (OTIC)"], "spl_id": "45d262c9-d942-0c46-e063-6394a90aae60", "openfda": {"nui": ["N0000175937", "M0023650"], "upc": ["0369315320105", "0369315320051"], "unii": ["A4P49JAZ9H"], "rxcui": ["242446"], "spl_set_id": ["37456656-77c8-d74c-e063-6294a90ab729"], "pharm_class_cs": ["Quinolones [CS]"], "pharm_class_epc": ["Quinolone Antimicrobial [EPC]"], "manufacturer_name": ["Redpharm Drug"]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 BOTTLE, DROPPER (67296-2159-5)", "package_ndc": "67296-2159-5", "marketing_start_date": "20240301"}], "brand_name": "OFLOXACIN", "product_id": "67296-2159_45d262c9-d942-0c46-e063-6394a90aae60", "dosage_form": "SOLUTION", "pharm_class": ["Quinolone Antimicrobial [EPC]", "Quinolones [CS]"], "product_ndc": "67296-2159", "generic_name": "OFLOXACIN", "labeler_name": "Redpharm Drug", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OFLOXACIN", "active_ingredients": [{"name": "OFLOXACIN", "strength": "3 mg/mL"}], "application_number": "ANDA217903", "marketing_category": "ANDA", "marketing_start_date": "20240301", "listing_expiration_date": "20261231"}